Delayed Cord Clamping at Term Cesarean

Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term

The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.

Study Overview

• Status: Completed
• Conditions: Cesarean Delivery; Neonatal Health; Delayed Cord Clamping; Maternal Blood Loss
• Intervention / Treatment: Procedure: Umbilical cord clamping

Detailed Description

After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton gestation
• Scheduled cesarean delivery at term (>=37 weeks)

Exclusion Criteria:

• Placenta previa
• Placenta abruption
• Intrauterine growth restriction with abnormal Dopplers
• Fetal anomalies
• Known fetal anemia
• Planned cord blood banking
• Preeclampsia
• Significant maternal anemia (Hgb <=7)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Immediate cord clamping; Umbilical cord clamped within 15 seconds of delivery of baby	Procedure: Umbilical cord clamping; The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
EXPERIMENTAL: Delayed cord clamping; Umbilical cord clamped 60 seconds after delivery of baby	Procedure: Umbilical cord clamping; The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal change in hemoglobin on post-operative day #1	Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture	Baseline to postoperative day #1 (range 1-4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum hemorrhage	Incidence of postpartum hemorrhage, defined as EBL >1000cc	From day of surgery to postpartum discharge (average 3-4 days)
Estimated blood loss	Estimated blood loss at cesarean delivery, based on estimation provider team	Day of surgery
Need for Need for additional uterotonics	Administration of uterotonics (beyond standard pitocin) during cesarean	Day of surgery
Maternal blood transfusion	Transfusion of blood products during or after delivery	From day of surgery to postpartum discharge (average 3-4 days)
Venous cord blood Hgb/Hct	Obtained from cord blood sample	Day of delivery
Neonatal Hgb/Hct	Obtained from neonatal heel stick	Day 0-2 of life
APGAR scores	Assigned at delivery	Day of delivery
Need for phototherapy for jaundice	Any use of phototherapy	From birth to hospital discharge (average 3-4 days)

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Study Chair: Cynthia Gyamfi-Bannerman, MD, Columbia University

Publications and helpful links

General Publications

• Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): March 31, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Cesarean delivery; Delayed cord clamping; Maternal blood loss; Neonatal health
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: AAAR2937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No